Available Courses

Results (151)




Course Title Course Date Location
European Regulatory Procedures - Comprehensive Overview of EMA and National Requirements™ Dec 05, 2016 - Dec 06, 2016 Berlin, Germany
Good Laboratory Practices (GLP) for Pre-Clinical Testing Dec 05, 2016 - Dec 07, 2016 Malvern, PA United States
Introduction to Effective Medical Writing Dec 05, 2016 - Dec 06, 2016 Malvern, PA United States
Water Purification Systems for Regulated Industries - Design, Chemistry and Validation Dec 05, 2016 - Dec 06, 2016 Malvern, PA United States
Heating, Ventilation, and Air Conditioning (HVAC) in a Regulated Environment Dec 07, 2016 - Dec 09, 2016 Malvern, PA United States
Process Validation for Medical Devices Dec 07, 2016 - Dec 09, 2016 Berlin, Germany
QbD: Product and Process Optimization using Design of Experiments (DoE) Dec 07, 2016 - Dec 09, 2016 Berlin, Germany
Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries Dec 07, 2016 - Dec 09, 2016 Malvern, PA United States
Adverse Drug Events – Reporting & Regulatory Requirements™ Dec 12, 2016 - Dec 13, 2016 Malvern, PA United States
Best Practices for an Effective Cleaning Validation Program Dec 12, 2016 - Dec 13, 2016 Berlin, Germany
Development and Validation of Bioanalytical Assays for Biologics: Quantitation (PK) and Immunogenicity Assays Dec 12, 2016 - Dec 13, 2016 Los Angeles, CA United States
Good Manufacturing Practices (cGMP) Dec 12, 2016 - Dec 14, 2016 Malvern, PA United States
Good Clinical Practices (GCP) – Understanding and Implementing the Current Global Requirements Dec 14, 2016 - Dec 16, 2016 Malvern, PA United States
Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices Dec 14, 2016 - Dec 15, 2016 Malvern, PA United States
Validation of Computer Systems Dec 14, 2016 - Dec 15, 2016 Los Angeles, CA United States
Introduction to Medical Device Submissions – 510(k)s, PMAs, and Exemptions Jan 23, 2017 - Jan 24, 2017 Malvern, PA United States
Good Laboratory Practices (GLP) for Pre-Clinical Testing Jan 25, 2017 - Jan 27, 2017 Berlin, Germany
Introduction to Medical Combination Products Jan 25, 2017 - Jan 27, 2017 Malvern, PA United States
Product Quality Reviews Jan 26, 2017 - Jan 27, 2017 Los Angeles, CA United States
Auditing and Qualifying Suppliers and Vendors – An Effective Risk Based Approach™ Jan 30, 2017 - Jan 31, 2017 Malvern, PA United States
Advanced Topics in Biostatistics for Non-Statisticians™ Feb 02, 2017 - Feb 03, 2017 Malvern, PA United States
Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Products Feb 02, 2017 - Feb 03, 2017 Malvern, PA United States
Comprehensive Overview of FDA Regulatory Compliance for Medical Devices™ Feb 06, 2017 - Feb 07, 2017 Malvern, PA United States
Introduction to Statistical Analysis of Laboratory Data Feb 06, 2017 - Feb 07, 2017 Malvern, PA United States
Water Purification Systems for Regulated Industries - Design, Chemistry and Validation Feb 06, 2017 - Feb 07, 2017 Los Angeles, CA United States
Clinical Document Management – A Trial-by-Trial Approach to Compliance Feb 07, 2017 - Feb 08, 2017 Los Angeles, CA United States
Biostatistics for Non-Statisticians Feb 08, 2017 - Feb 10, 2017 Malvern, PA United States
Clinical Trial Design For Medical Devices™ Feb 08, 2017 - Feb 09, 2017 Malvern, PA United States
Heating, Ventilation, and Air Conditioning (HVAC) in a Regulated Environment Feb 08, 2017 - Feb 10, 2017 Los Angeles, CA United States
Selecting and Managing CROs Feb 09, 2017 - Feb 10, 2017 Los Angeles, CA United States
Integration of Risk Management Principles and Activities into the Quality System Feb 13, 2017 - Feb 14, 2017 Berlin, Germany
The Drug Development Process - From Discovery to Commercialization™ Feb 13, 2017 - Feb 15, 2017 Los Angeles, CA United States
Writing Effective Standard Operating Procedures and Other Process Documents Feb 13, 2017 - Feb 14, 2017 Los Angeles, CA United States
Effective Internal and External Quality Assurance Auditing for FDA Regulated Industries™ Feb 15, 2017 - Feb 16, 2017 Malvern, PA United States
Writing in the Regulated Environment When English Is Your Second Language Feb 15, 2017 - Feb 16, 2017 Los Angeles, CA United States
EU Quality Dossier Submission Requirements Feb 23, 2017 - Feb 24, 2017 Berlin, Germany
Biostatistics for Non-Statisticians Mar 01, 2017 - Mar 03, 2017 Berlin, Germany
Pharmaceutical Production Batch Record Review Mar 02, 2017 - Mar 03, 2017 Malvern, PA United States
FDA Inspections: What Regulators Expect and How to Prepare Mar 06, 2017 - Mar 07, 2017 Malvern, PA United States
Pharmaceutical and Biopharmaceutical Quality Control Laboratories - A Regulatory Compliance Primer Mar 06, 2017 - Mar 07, 2017 Malvern, PA United States
Preparing the CMC Section for NDAs/INDs/CTDs Mar 06, 2017 - Mar 07, 2017 Los Angeles, CA United States
Introduction to Molecular Biology Techniques – Applications in the Biotechnology and Pharmaceutical Industries Mar 08, 2017 - Mar 10, 2017 Malvern, PA United States
Pharmaceutical Root Cause Analysis of Failures & Deviations - Developing an Effective CAPA Strategy Mar 08, 2017 - Mar 10, 2017 Malvern, PA United States
Process Validation for Drugs and Biologics Mar 08, 2017 - Mar 09, 2017 Malvern, PA United States
Project Management for Medical Device Product Development Mar 09, 2017 - Mar 10, 2017 Los Angeles, CA United States
Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products™ Mar 13, 2017 - Mar 14, 2017 Los Angeles, CA United States
GCP Audits - Best Practices for Ensuring Compliance & Detecting Fraud and Misconduct in Clinical Trials Mar 13, 2017 - Mar 14, 2017 Malvern, PA United States
Writing in the Regulated Environment When English Is Your Second Language Mar 13, 2017 - Mar 14, 2017 Berlin, Germany
Active Pharmaceutical Ingredient (API) & Drug Product Specifications – From Clinical Development to Market Approval Mar 14, 2017 - Mar 15, 2017 Malvern, PA United States
Clinical Trial Project Management for Phase 1 thru Phase 4: Best Practices™ Mar 15, 2017 - Mar 17, 2017 Berlin, Germany
Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products Mar 16, 2017 - Mar 17, 2017 Malvern, PA United States
Cleanroom Microbiology for the Non-Microbiologist Mar 20, 2017 - Mar 21, 2017 Malvern, PA United States
Preparation of FDA Submissions and Communicating with the FDA (INDs, NDAs, BLAs, ANDAs, Biosimilars, Post-Approval Supplements) Mar 20, 2017 - Mar 21, 2017 Malvern, PA United States
Validation of Computer Systems Mar 20, 2017 - Mar 21, 2017 Malvern, PA United States
Stability Programs for Determining Product Shelf Life – From Clinical Development to Market Approval Mar 22, 2017 - Mar 23, 2017 Malvern, PA United States
Understanding Sterilization Methods for Products and Devices Mar 22, 2017 - Mar 23, 2017 Malvern, PA United States
Good Manufacturing Practices (cGMP) Mar 27, 2017 - Mar 29, 2017 Los Angeles, CA United States
Lyophilization Technology – Practical Application of the Scientific Principles Mar 27, 2017 - Mar 28, 2017 Malvern, PA United States
The Drug Development Process - From Discovery to Commercialization™ Mar 27, 2017 - Mar 29, 2017 Berlin, Germany
The Electronic Common Technical Document (eCTD): Strategies & Tools to Build a Successful Submission Mar 27, 2017 - Mar 28, 2017 Malvern, PA United States
US Cosmetic Regulation - FDA CFR Title 21 Mar 29, 2017 - Mar 31, 2017 Malvern, PA United States
Design Control for Medical Device Professionals™ Apr 03, 2017 - Apr 04, 2017 Los Angeles, CA United States
European Regulatory Procedures - Comprehensive Overview of EMA and National Requirements™ Apr 03, 2017 - Apr 04, 2017 Malvern, PA United States
Introduction to Medical Device Submissions – 510(k)s, PMAs, and Exemptions Apr 03, 2017 - Apr 04, 2017 Berlin, Germany
Design Validation, Verification, and Risk Analysis for Medical Device Professionals Apr 05, 2017 - Apr 06, 2017 Los Angeles, CA United States
Introduction to Medical Combination Products Apr 05, 2017 - Apr 07, 2017 Berlin, Germany
EU Quality Dossier Submission Requirements Apr 06, 2017 - Apr 07, 2017 Malvern, PA United States
Validation of Computer Systems Apr 20, 2017 - Apr 21, 2017 Berlin, Germany
Introduction to Medical Device Submissions – 510(k)s, PMAs, and Exemptions Apr 24, 2017 - Apr 25, 2017 Los Angeles, CA United States
Lyophilization Technology – Practical Application of the Scientific Principles Apr 24, 2017 - Apr 25, 2017 Berlin, Germany
The Regulated Medical Marijuana Business - From Concept to Product Sale Apr 24, 2017 - Apr 25, 2017 Los Angeles, CA United States
Introduction to Medical Combination Products Apr 26, 2017 - Apr 28, 2017 Los Angeles, CA United States
Best Practices for an Effective Cleaning Validation Program Apr 27, 2017 - Apr 28, 2017 Malvern, PA United States
Development and Validation of Bioanalytical Assays for Biologics: Quantitation (PK) and Immunogenicity Assays Apr 27, 2017 - Apr 28, 2017 Berlin, Germany
Product Quality Reviews May 01, 2017 - May 02, 2017 Malvern, PA United States
Stability Programs for Determining Product Shelf Life – From Clinical Development to Market Approval May 04, 2017 - May 05, 2017 Berlin, Germany
CMC Regulatory Compliance for Biopharmaceuticals, Biosimilars and Other Biologics May 08, 2017 - May 10, 2017 Berlin, Germany
Effective Document Management for the Pharmaceutical, Biotech & Medical Device Industries™ May 08, 2017 - May 09, 2017 Malvern, PA United States
Formulation Design and Troubleshooting of Dry Dosage Forms (Tablets and Capsules) May 08, 2017 - May 09, 2017 Malvern, PA United States
GMPs for OTC and Cosmetic Products – US and Global Requirements May 08, 2017 - May 09, 2017 Malvern, PA United States
Global Personal Care Market & Regulatory Overview May 10, 2017 - May 12, 2017 Malvern, PA United States
Granulation, Tableting and Capsule Technology May 10, 2017 - May 11, 2017 Malvern, PA United States
Writing Effective Standard Operating Procedures and Other Process Documents May 10, 2017 - May 11, 2017 Malvern, PA United States
Preparation of FDA Submissions and Communicating with the FDA (INDs, NDAs, BLAs, ANDAs, Biosimilars, Post-Approval Supplements) May 11, 2017 - May 12, 2017 Berlin, Germany
Integration of Risk Management Principles and Activities into the Quality System May 15, 2017 - May 16, 2017 Malvern, PA United States
Preparing the CMC Section for MAAs-IMPDs May 15, 2017 - May 16, 2017 Berlin, Germany
Process Validation for Medical Devices May 17, 2017 - May 19, 2017 Malvern, PA United States
Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems May 22, 2017 - May 23, 2017 Malvern, PA United States
Medical Devices: EU Directives, Guidance, CE Marking and ISO Standard Certifications May 24, 2017 - May 25, 2017 Malvern, PA United States
Design Control for Medical Device Professionals™ May 30, 2017 - May 31, 2017 Berlin, Germany
QA/QC Strategy for Biologics and Biopharmaceuticals May 31, 2017 - Jun 02, 2017 Los Angeles, CA United States
Design Validation, Verification, and Risk Analysis for Medical Device Professionals Jun 01, 2017 - Jun 02, 2017 Berlin, Germany
Auditing and Qualifying Suppliers and Vendors – An Effective Risk Based Approach™ Jun 05, 2017 - Jun 06, 2017 Los Angeles, CA United States
CMC Regulatory Compliance for Biopharmaceuticals, Biosimilars and Other Biologics Jun 05, 2017 - Jun 07, 2017 Los Angeles, CA United States
European Union Regulatory Issues – New Product Development™ Jun 05, 2017 - Jun 06, 2017 Berlin, Germany
Preparing the CMC Section for NDAs/INDs/CTDs Jun 05, 2017 - Jun 06, 2017 Malvern, PA United States
Filing Variations in the European Union™ Jun 07, 2017 - Jun 08, 2017 Berlin, Germany
Global Review of Sunscreen Science, Products & Regulation Jun 07, 2017 - Jun 09, 2017 Malvern, PA United States
Preparation of FDA Submissions and Communicating with the FDA (INDs, NDAs, BLAs, ANDAs, Biosimilars, Post-Approval Supplements) Jun 08, 2017 - Jun 09, 2017 Los Angeles, CA United States
FDA Inspections: What Regulators Expect and How to Prepare Jun 12, 2017 - Jun 13, 2017 Los Angeles, CA United States
Pharmaceutical Root Cause Analysis of Failures & Deviations - Developing an Effective CAPA Strategy Jun 14, 2017 - Jun 16, 2017 Los Angeles, CA United States
Stability Programs for Determining Product Shelf Life – From Clinical Development to Market Approval Jun 19, 2017 - Jun 20, 2017 Los Angeles, CA United States
GCP Audits - Best Practices for Ensuring Compliance & Detecting Fraud and Misconduct in Clinical Trials Jul 17, 2017 - Jul 18, 2017 Los Angeles, CA United States
Introduction to Statistical Analysis of Laboratory Data Jul 17, 2017 - Jul 18, 2017 Los Angeles, CA United States
Development and Validation of Bioanalytical Assays for Biologics: Quantitation (PK) and Immunogenicity Assays Jul 18, 2017 - Jul 19, 2017 Malvern, PA United States
Biostatistics for Non-Statisticians Jul 19, 2017 - Jul 21, 2017 Los Angeles, CA United States
Lyophilization Technology – Practical Application of the Scientific Principles Jul 20, 2017 - Jul 21, 2017 Los Angeles, CA United States
Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products™ Jul 24, 2017 - Jul 25, 2017 Malvern, PA United States
Effective Document Management for the Pharmaceutical, Biotech & Medical Device Industries™ Jul 24, 2017 - Jul 25, 2017 Los Angeles, CA United States
Pharmaceutical and Biopharmaceutical Quality Control Laboratories - A Regulatory Compliance Primer Jul 24, 2017 - Jul 25, 2017 Los Angeles, CA United States
Clinical Trial Project Management for Phase 1 thru Phase 4: Best Practices™ Jul 26, 2017 - Jul 28, 2017 Los Angeles, CA United States
Process Validation for Drugs and Biologics Jul 26, 2017 - Jul 27, 2017 Los Angeles, CA United States
Good Laboratory Practices (GLP) for Pre-Clinical Testing Aug 07, 2017 - Aug 09, 2017 Los Angeles, CA United States
Introduction to Effective Medical Writing Aug 07, 2017 - Aug 08, 2017 Los Angeles, CA United States
Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries Aug 09, 2017 - Aug 11, 2017 Los Angeles, CA United States
Clinical Document Management – A Trial-by-Trial Approach to Compliance Aug 21, 2017 - Aug 22, 2017 Malvern, PA United States
Clinical Trial Project Management for Phase 1 thru Phase 4: Best Practices™ Aug 23, 2017 - Aug 25, 2017 Malvern, PA United States
Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products Sep 07, 2017 - Sep 08, 2017 Los Angeles, CA United States
Project Management for Medical Device Product Development Sep 11, 2017 - Sep 12, 2017 Malvern, PA United States
Global Review of Sunscreen Science, Products & Regulation Sep 13, 2017 - Sep 15, 2017 Los Angeles, CA United States
Active Pharmaceutical Ingredient (API) & Drug Product Specifications – From Clinical Development to Market Approval Sep 18, 2017 - Sep 19, 2017 Los Angeles, CA United States
Best Practices for an Effective Cleaning Validation Program Sep 18, 2017 - Sep 19, 2017 Los Angeles, CA United States
Introduction to Effective Medical Writing Sep 25, 2017 - Sep 26, 2017 Berlin, Germany
Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries Sep 27, 2017 - Sep 29, 2017 Berlin, Germany
The Regulated Medical Marijuana Business - From Concept to Product Sale Oct 04, 2017 - Oct 05, 2017 Malvern, PA United States
Medical Devices: EU Directives, Guidance, CE Marking and ISO Standard Certifications Oct 12, 2017 - Oct 13, 2017 Berlin, Germany
CMC Regulatory Compliance for Biopharmaceuticals, Biosimilars and Other Biologics Oct 18, 2017 - Oct 20, 2017 Malvern, PA United States
Selecting and Managing CROs Oct 19, 2017 - Oct 20, 2017 Malvern, PA United States
The Electronic Common Technical Document (eCTD): Strategies & Tools to Build a Successful Submission Oct 23, 2017 - Oct 24, 2017 Los Angeles, CA United States
Water Purification Systems for Regulated Industries - Design, Chemistry and Validation Oct 23, 2017 - Oct 24, 2017 Berlin, Germany
Heating, Ventilation, and Air Conditioning (HVAC) in a Regulated Environment Oct 25, 2017 - Oct 27, 2017 Berlin, Germany
QA/QC Strategy for Biologics and Biopharmaceuticals Oct 25, 2017 - Oct 27, 2017 Malvern, PA United States
US Cosmetic Regulation - FDA CFR Title 21 Oct 25, 2017 - Oct 27, 2017 Los Angeles, CA United States
Writing in the Regulated Environment When English Is Your Second Language Oct 25, 2017 - Oct 26, 2017 Malvern, PA United States
Auditing and Qualifying Suppliers and Vendors – An Effective Risk Based Approach™ Oct 30, 2017 - Oct 31, 2017 Berlin, Germany
Formulation Design and Troubleshooting of Dry Dosage Forms (Tablets and Capsules) Oct 30, 2017 - Oct 31, 2017 Berlin, Germany
Granulation, Tableting and Capsule Technology Nov 01, 2017 - Nov 02, 2017 Berlin, Germany
FDA Inspections: What Regulators Expect and How to Prepare Nov 06, 2017 - Nov 07, 2017 Berlin, Germany
GMPs for OTC and Cosmetic Products – US and Global Requirements Nov 06, 2017 - Nov 07, 2017 Los Angeles, CA United States
Integration of Risk Management Principles and Activities into the Quality System Nov 06, 2017 - Nov 07, 2017 Los Angeles, CA United States
Global Personal Care Market & Regulatory Overview Nov 08, 2017 - Nov 10, 2017 Los Angeles, CA United States
Pharmaceutical Root Cause Analysis of Failures & Deviations - Developing an Effective CAPA Strategy Nov 08, 2017 - Nov 10, 2017 Berlin, Germany
Process Validation for Medical Devices Nov 08, 2017 - Nov 10, 2017 Los Angeles, CA United States
Medical Devices: EU Directives, Guidance, CE Marking and ISO Standard Certifications Nov 13, 2017 - Nov 14, 2017 Los Angeles, CA United States
Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems Nov 15, 2017 - Nov 16, 2017 Los Angeles, CA United States
Design Control for Medical Device Professionals™ Nov 28, 2017 - Nov 29, 2017 Malvern, PA United States
Design Validation, Verification, and Risk Analysis for Medical Device Professionals Nov 30, 2017 - Dec 01, 2017 Malvern, PA United States
Effective Document Management for the Pharmaceutical, Biotech & Medical Device Industries™ Dec 11, 2017 - Dec 12, 2017 Berlin, Germany
Understanding & Implementing the New EU Clinical Trial Regulation Dec 11, 2017 - Dec 12, 2017 Malvern, PA United States
The Drug Development Process - From Discovery to Commercialization™ Dec 13, 2017 - Dec 15, 2017 Malvern, PA United States
Writing Effective Standard Operating Procedures and Other Process Documents Dec 13, 2017 - Dec 14, 2017 Berlin, Germany